Screening Methods For Heparin Manufacturers

To ensure the safety of heparin products in the United States market, the FDA has asked companies that manufacture heparin-containing products to test the heparin active pharmaceutical ingredient (API) used in those products using capillary electrophoresis (CE) and the updated proton nuclear magnetic resonance (H-NMR) methods provided in the “Screening Methods” section of this website. As part of FDA’s ongoing investigation, the FDA has updated the information it is requesting from manufacturers to allow a better understanding of the complex global heparin supply chain and to ensure the safety of heparin containing products for use in the United States.

In order to promote consistency in the information reporting and gain the most benefit from these reporting activities, the FDA is requesting monthly updates from manufacturers on all heparin API testing using the template provided below. However, FDA should be notified of any positive results within 3 dates of the test being conducted. In addition, FDA requests that manufacturers submit the associated NMR spectra and CE electropherograms that support the testing results to the address below.

Please send all test results to the U.S. FDA at: cderrecalls@cder.fda.gov

Leave a Reply